A placebo‐controlled study of interaction between nabumetone and acenocoumarol

Aims The use of nonsteroidal anti‐inflammatory drugs (NSAIDs) in patients treated with oral anticoagulants is generally discouraged due to the risk of interactions that could increase the risk of bleeding complications. Available data suggest the NSAID, nabumetone, does not produce such an interacti...

Ausführliche Beschreibung

Gespeichert in:
Bibliographische Detailangaben
Veröffentlicht in:British journal of clinical pharmacology 1999-04, Vol.47 (4), p.441-444
Hauptverfasser: Pardo, García‐Losa, Fernández‐Pavón, Del Castillo, Pascual‐García, García‐Méndez, Dal‐Ré
Format: Artikel
Sprache:eng
Schlagworte:
Online-Zugang:Volltext
Tags: Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
container_end_page 444
container_issue 4
container_start_page 441
container_title British journal of clinical pharmacology
container_volume 47
creator Pardo
García‐Losa
Fernández‐Pavón
Del Castillo
Pascual‐García
García‐Méndez
Dal‐Ré
description Aims The use of nonsteroidal anti‐inflammatory drugs (NSAIDs) in patients treated with oral anticoagulants is generally discouraged due to the risk of interactions that could increase the risk of bleeding complications. Available data suggest the NSAID, nabumetone, does not produce such an interaction. We investigated whether nabumetone would interact with acenocoumarol, an oral anticoagulant widely used in some European countries. Methods A double‐blind, randomized, placebo‐controlled study was conducted evaluating nabumetone (1–2 g daily for up to 4 weeks) in osteoarthritis patients with thromboembolic risk previously stabilized on acenocoumarol. The primary efficacy end point was the proportion of patients whose International Normalized Ratio (INR) remained within established margins and whose acenocoumarol dose was not changed. Fifty‐six patients were randomized to receive nabumetone (n=27) or placebo (n=29). Results Eighteen patients in each group (67% for nabumetone and 62% for placebo) completed the study without showing INR or acenocoumarol dose changes, and were considered as study successes. Nine patients (33%) with nabumetone and 11 (38%) with placebo were considered study failures in the intention‐to‐treat analysis (one patient on nabumetone and four on placebo did not complete the study due to reasons not related to INR and acenocoumarol dose changes). No significant differences were found between groups with regard to study successes. There were two minor bleeding complications, one in each group. Six patients per group presented with eight adverse experiences in each group. Conclusions Treatment with nabumetone did not alter INR levels compared with placebo in patients stabilized on oral acenocoumarol who require NSAID therapy. These results suggest that nabumetone does not produce a clinically relevant interaction with acenocoumarol. In orally anticoagulated patients without other associated risk factors, treatment with nabumetone for up to 4 weeks does not require increased monitoring of INR levels.
doi_str_mv 10.1046/j.1365-2125.1999.00916.x
format Article
fullrecord <record><control><sourceid>wiley_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_2014245</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>BCP916</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4986-519ea4f590485719e385617e6c10fce07cbf2eb13e656a45c905b2356a5512273</originalsourceid><addsrcrecordid>eNqNkM1KAzEUhYMotv68gmThtmNuMsk0IEIt_oFgF7oOmfSOTpkmZWZq252P4DP6JKZWqu5c5YZ7zrmHjxAKLAGWqrNJAkLJHgcuE9BaJ4xpUMlyh3S3i13SZYKpnuQSOuSgaSaMgQAl90kHGBeCA-uS0YDOKuswDx9v7y74tg5VhWPatPPxioaClr7F2rq2DJ7m2C4QPfU2n0-xDR6p9WMa7T64MJ_aaD4ie4WtGjz-fg_J0_XV4_C2d_9wczcc3PdcqvuxFWi0aSE1S_syix_RlwoyVA5Y4ZBlLi845iBQSWVT6TSTORdxlhI4z8Qhudjkzub5FMexQlvbyszqMtZYmWBL83fjyxfzHF4NZ5DyVMaA_ibA1aFpaiy2XmBmTdlMzBqmWcM0a8rmi7JZRuvJ79u_jBusUXD6LbCNs1VRW-_K5keXSa5FGmXnG9mirHD17_vmcjiKg_gE9V-aLw</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype></control><display><type>article</type><title>A placebo‐controlled study of interaction between nabumetone and acenocoumarol</title><source>Wiley Online Library - AutoHoldings Journals</source><source>MEDLINE</source><source>EZB-FREE-00999 freely available EZB journals</source><source>Wiley Online Library (Open Access Collection)</source><creator>Pardo ; García‐Losa ; Fernández‐Pavón ; Del Castillo ; Pascual‐García ; García‐Méndez ; Dal‐Ré</creator><creatorcontrib>Pardo ; García‐Losa ; Fernández‐Pavón ; Del Castillo ; Pascual‐García ; García‐Méndez ; Dal‐Ré</creatorcontrib><description>Aims The use of nonsteroidal anti‐inflammatory drugs (NSAIDs) in patients treated with oral anticoagulants is generally discouraged due to the risk of interactions that could increase the risk of bleeding complications. Available data suggest the NSAID, nabumetone, does not produce such an interaction. We investigated whether nabumetone would interact with acenocoumarol, an oral anticoagulant widely used in some European countries. Methods A double‐blind, randomized, placebo‐controlled study was conducted evaluating nabumetone (1–2 g daily for up to 4 weeks) in osteoarthritis patients with thromboembolic risk previously stabilized on acenocoumarol. The primary efficacy end point was the proportion of patients whose International Normalized Ratio (INR) remained within established margins and whose acenocoumarol dose was not changed. Fifty‐six patients were randomized to receive nabumetone (n=27) or placebo (n=29). Results Eighteen patients in each group (67% for nabumetone and 62% for placebo) completed the study without showing INR or acenocoumarol dose changes, and were considered as study successes. Nine patients (33%) with nabumetone and 11 (38%) with placebo were considered study failures in the intention‐to‐treat analysis (one patient on nabumetone and four on placebo did not complete the study due to reasons not related to INR and acenocoumarol dose changes). No significant differences were found between groups with regard to study successes. There were two minor bleeding complications, one in each group. Six patients per group presented with eight adverse experiences in each group. Conclusions Treatment with nabumetone did not alter INR levels compared with placebo in patients stabilized on oral acenocoumarol who require NSAID therapy. These results suggest that nabumetone does not produce a clinically relevant interaction with acenocoumarol. In orally anticoagulated patients without other associated risk factors, treatment with nabumetone for up to 4 weeks does not require increased monitoring of INR levels.</description><identifier>ISSN: 0306-5251</identifier><identifier>EISSN: 1365-2125</identifier><identifier>DOI: 10.1046/j.1365-2125.1999.00916.x</identifier><identifier>PMID: 10233210</identifier><identifier>CODEN: BCPHBM</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Science Ltd</publisher><subject>acenocoumarol ; Acenocoumarol - pharmacology ; Adult ; Aged ; Anti-Inflammatory Agents, Non-Steroidal - pharmacology ; Anticoagulants - pharmacology ; Biological and medical sciences ; Blood. Blood coagulation. Reticuloendothelial system ; Butanones - pharmacology ; Double-Blind Method ; Drug Interaction ; Drug Interactions ; Female ; Humans ; interaction ; Male ; Medical sciences ; Middle Aged ; Nabumetone ; Pharmacology. Drug treatments ; Prospective Studies</subject><ispartof>British journal of clinical pharmacology, 1999-04, Vol.47 (4), p.441-444</ispartof><rights>1999 INIST-CNRS</rights><rights>1999 Blackwell Science Ltd 1999</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4986-519ea4f590485719e385617e6c10fce07cbf2eb13e656a45c905b2356a5512273</citedby><cites>FETCH-LOGICAL-c4986-519ea4f590485719e385617e6c10fce07cbf2eb13e656a45c905b2356a5512273</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1046%2Fj.1365-2125.1999.00916.x$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1046%2Fj.1365-2125.1999.00916.x$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>230,309,310,314,780,784,789,790,885,1417,1433,23930,23931,25140,27924,27925,45574,45575,46409,46833</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&amp;idt=1752934$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/10233210$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Pardo</creatorcontrib><creatorcontrib>García‐Losa</creatorcontrib><creatorcontrib>Fernández‐Pavón</creatorcontrib><creatorcontrib>Del Castillo</creatorcontrib><creatorcontrib>Pascual‐García</creatorcontrib><creatorcontrib>García‐Méndez</creatorcontrib><creatorcontrib>Dal‐Ré</creatorcontrib><title>A placebo‐controlled study of interaction between nabumetone and acenocoumarol</title><title>British journal of clinical pharmacology</title><addtitle>Br J Clin Pharmacol</addtitle><description>Aims The use of nonsteroidal anti‐inflammatory drugs (NSAIDs) in patients treated with oral anticoagulants is generally discouraged due to the risk of interactions that could increase the risk of bleeding complications. Available data suggest the NSAID, nabumetone, does not produce such an interaction. We investigated whether nabumetone would interact with acenocoumarol, an oral anticoagulant widely used in some European countries. Methods A double‐blind, randomized, placebo‐controlled study was conducted evaluating nabumetone (1–2 g daily for up to 4 weeks) in osteoarthritis patients with thromboembolic risk previously stabilized on acenocoumarol. The primary efficacy end point was the proportion of patients whose International Normalized Ratio (INR) remained within established margins and whose acenocoumarol dose was not changed. Fifty‐six patients were randomized to receive nabumetone (n=27) or placebo (n=29). Results Eighteen patients in each group (67% for nabumetone and 62% for placebo) completed the study without showing INR or acenocoumarol dose changes, and were considered as study successes. Nine patients (33%) with nabumetone and 11 (38%) with placebo were considered study failures in the intention‐to‐treat analysis (one patient on nabumetone and four on placebo did not complete the study due to reasons not related to INR and acenocoumarol dose changes). No significant differences were found between groups with regard to study successes. There were two minor bleeding complications, one in each group. Six patients per group presented with eight adverse experiences in each group. Conclusions Treatment with nabumetone did not alter INR levels compared with placebo in patients stabilized on oral acenocoumarol who require NSAID therapy. These results suggest that nabumetone does not produce a clinically relevant interaction with acenocoumarol. In orally anticoagulated patients without other associated risk factors, treatment with nabumetone for up to 4 weeks does not require increased monitoring of INR levels.</description><subject>acenocoumarol</subject><subject>Acenocoumarol - pharmacology</subject><subject>Adult</subject><subject>Aged</subject><subject>Anti-Inflammatory Agents, Non-Steroidal - pharmacology</subject><subject>Anticoagulants - pharmacology</subject><subject>Biological and medical sciences</subject><subject>Blood. Blood coagulation. Reticuloendothelial system</subject><subject>Butanones - pharmacology</subject><subject>Double-Blind Method</subject><subject>Drug Interaction</subject><subject>Drug Interactions</subject><subject>Female</subject><subject>Humans</subject><subject>interaction</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Nabumetone</subject><subject>Pharmacology. Drug treatments</subject><subject>Prospective Studies</subject><issn>0306-5251</issn><issn>1365-2125</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>1999</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkM1KAzEUhYMotv68gmThtmNuMsk0IEIt_oFgF7oOmfSOTpkmZWZq252P4DP6JKZWqu5c5YZ7zrmHjxAKLAGWqrNJAkLJHgcuE9BaJ4xpUMlyh3S3i13SZYKpnuQSOuSgaSaMgQAl90kHGBeCA-uS0YDOKuswDx9v7y74tg5VhWPatPPxioaClr7F2rq2DJ7m2C4QPfU2n0-xDR6p9WMa7T64MJ_aaD4ie4WtGjz-fg_J0_XV4_C2d_9wczcc3PdcqvuxFWi0aSE1S_syix_RlwoyVA5Y4ZBlLi845iBQSWVT6TSTORdxlhI4z8Qhudjkzub5FMexQlvbyszqMtZYmWBL83fjyxfzHF4NZ5DyVMaA_ibA1aFpaiy2XmBmTdlMzBqmWcM0a8rmi7JZRuvJ79u_jBusUXD6LbCNs1VRW-_K5keXSa5FGmXnG9mirHD17_vmcjiKg_gE9V-aLw</recordid><startdate>199904</startdate><enddate>199904</enddate><creator>Pardo</creator><creator>García‐Losa</creator><creator>Fernández‐Pavón</creator><creator>Del Castillo</creator><creator>Pascual‐García</creator><creator>García‐Méndez</creator><creator>Dal‐Ré</creator><general>Blackwell Science Ltd</general><general>Blackwell Science</general><general>Blackwell Science Inc</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>5PM</scope></search><sort><creationdate>199904</creationdate><title>A placebo‐controlled study of interaction between nabumetone and acenocoumarol</title><author>Pardo ; García‐Losa ; Fernández‐Pavón ; Del Castillo ; Pascual‐García ; García‐Méndez ; Dal‐Ré</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4986-519ea4f590485719e385617e6c10fce07cbf2eb13e656a45c905b2356a5512273</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>1999</creationdate><topic>acenocoumarol</topic><topic>Acenocoumarol - pharmacology</topic><topic>Adult</topic><topic>Aged</topic><topic>Anti-Inflammatory Agents, Non-Steroidal - pharmacology</topic><topic>Anticoagulants - pharmacology</topic><topic>Biological and medical sciences</topic><topic>Blood. Blood coagulation. Reticuloendothelial system</topic><topic>Butanones - pharmacology</topic><topic>Double-Blind Method</topic><topic>Drug Interaction</topic><topic>Drug Interactions</topic><topic>Female</topic><topic>Humans</topic><topic>interaction</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Nabumetone</topic><topic>Pharmacology. Drug treatments</topic><topic>Prospective Studies</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Pardo</creatorcontrib><creatorcontrib>García‐Losa</creatorcontrib><creatorcontrib>Fernández‐Pavón</creatorcontrib><creatorcontrib>Del Castillo</creatorcontrib><creatorcontrib>Pascual‐García</creatorcontrib><creatorcontrib>García‐Méndez</creatorcontrib><creatorcontrib>Dal‐Ré</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>British journal of clinical pharmacology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Pardo</au><au>García‐Losa</au><au>Fernández‐Pavón</au><au>Del Castillo</au><au>Pascual‐García</au><au>García‐Méndez</au><au>Dal‐Ré</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A placebo‐controlled study of interaction between nabumetone and acenocoumarol</atitle><jtitle>British journal of clinical pharmacology</jtitle><addtitle>Br J Clin Pharmacol</addtitle><date>1999-04</date><risdate>1999</risdate><volume>47</volume><issue>4</issue><spage>441</spage><epage>444</epage><pages>441-444</pages><issn>0306-5251</issn><eissn>1365-2125</eissn><coden>BCPHBM</coden><abstract>Aims The use of nonsteroidal anti‐inflammatory drugs (NSAIDs) in patients treated with oral anticoagulants is generally discouraged due to the risk of interactions that could increase the risk of bleeding complications. Available data suggest the NSAID, nabumetone, does not produce such an interaction. We investigated whether nabumetone would interact with acenocoumarol, an oral anticoagulant widely used in some European countries. Methods A double‐blind, randomized, placebo‐controlled study was conducted evaluating nabumetone (1–2 g daily for up to 4 weeks) in osteoarthritis patients with thromboembolic risk previously stabilized on acenocoumarol. The primary efficacy end point was the proportion of patients whose International Normalized Ratio (INR) remained within established margins and whose acenocoumarol dose was not changed. Fifty‐six patients were randomized to receive nabumetone (n=27) or placebo (n=29). Results Eighteen patients in each group (67% for nabumetone and 62% for placebo) completed the study without showing INR or acenocoumarol dose changes, and were considered as study successes. Nine patients (33%) with nabumetone and 11 (38%) with placebo were considered study failures in the intention‐to‐treat analysis (one patient on nabumetone and four on placebo did not complete the study due to reasons not related to INR and acenocoumarol dose changes). No significant differences were found between groups with regard to study successes. There were two minor bleeding complications, one in each group. Six patients per group presented with eight adverse experiences in each group. Conclusions Treatment with nabumetone did not alter INR levels compared with placebo in patients stabilized on oral acenocoumarol who require NSAID therapy. These results suggest that nabumetone does not produce a clinically relevant interaction with acenocoumarol. In orally anticoagulated patients without other associated risk factors, treatment with nabumetone for up to 4 weeks does not require increased monitoring of INR levels.</abstract><cop>Oxford, UK</cop><pub>Blackwell Science Ltd</pub><pmid>10233210</pmid><doi>10.1046/j.1365-2125.1999.00916.x</doi><tpages>4</tpages><oa>free_for_read</oa></addata></record>
fulltext fulltext
identifier ISSN: 0306-5251
ispartof British journal of clinical pharmacology, 1999-04, Vol.47 (4), p.441-444
issn 0306-5251
1365-2125
language eng
recordid cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_2014245
source Wiley Online Library - AutoHoldings Journals; MEDLINE; EZB-FREE-00999 freely available EZB journals; Wiley Online Library (Open Access Collection)
subjects acenocoumarol
Acenocoumarol - pharmacology
Adult
Aged
Anti-Inflammatory Agents, Non-Steroidal - pharmacology
Anticoagulants - pharmacology
Biological and medical sciences
Blood. Blood coagulation. Reticuloendothelial system
Butanones - pharmacology
Double-Blind Method
Drug Interaction
Drug Interactions
Female
Humans
interaction
Male
Medical sciences
Middle Aged
Nabumetone
Pharmacology. Drug treatments
Prospective Studies
title A placebo‐controlled study of interaction between nabumetone and acenocoumarol
url https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-24T13%3A55%3A49IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-wiley_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=A%20placebo%E2%80%90controlled%20study%20of%20interaction%20between%20nabumetone%20and%20acenocoumarol&rft.jtitle=British%20journal%20of%20clinical%20pharmacology&rft.au=Pardo&rft.date=1999-04&rft.volume=47&rft.issue=4&rft.spage=441&rft.epage=444&rft.pages=441-444&rft.issn=0306-5251&rft.eissn=1365-2125&rft.coden=BCPHBM&rft_id=info:doi/10.1046/j.1365-2125.1999.00916.x&rft_dat=%3Cwiley_pubme%3EBCP916%3C/wiley_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_id=info:pmid/10233210&rfr_iscdi=true